Effects of the WHO 8-step Wheelchair Service Delivery Process on Wheelchair Users in El Salvador: a Cohort Study — WUV  

Wheelchair Users Clinical Trial

Official title: Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador

Status Completed

Clinical Trial Summary

The objective of this study was to test the hypotheses that wheelchair-related health, wheelchair skills, wheelchair use, poverty probability, and quality of life would improve; and that the number of wheelchair repairs required, adverse events, caregiver burden and the level of assistance provided would decrease after the delivery of manual wheelchairs following the World Health Organization (WHO) 8-step service-delivery process.

This was a longitudinal, within-subject study design including 247 manual wheelchair users in El Salvador. The intervention consisted of the WHO 8-step process as well as maintenance reminders. Outcome assessments on wheelchair-related health, wheelchair skills, wheelchair repairs required, adverse events, caregiver burden and the level of assistance, poverty probability, and quality of life were performed via structured interviews at the initial assessment, at wheelchair delivery, and at 3- and 6-month follow-up. Wheelchair use was measured with dataloggers at assessment, delivery and 3-month follow-up.

Clinical Trial Description

Ethics approval was granted from the National Committee on Research Ethics for Health in El Salvador (CNEIS/2018/043) and the Institutional Review Board at the University of Pittsburgh (number PRO18010578). Written informed consent was obtained from all participants before implementing study procedures.

All procedures of the study were conducted at 11 different rehabilitation centers, that served as wheelchair service delivery centers, in El Salvador.

A consecutive sampling method was used to select participants using the waitlists at the 11 rehabilitation centers. The investigators recruited wheelchair users and their caregivers.

Following the initial assessment, all participants were placed on a waiting list until wheelchairs and services were available. All study participants were provided with a new wheelchair (standard, active, or all-terrain model), a wheelchair cushion, and wheelchair services, delivered by trained wheelchair service providers, according to the WHO 8-step wheelchair service delivery process including assessment, fitting, and a 30-minute individual or group training on 7 wheelchair skills, device care, and pressure injury prevention techniques.

In addition, all wheelchairs were provided with a basic contour cushion made of polyurethane foam. However, whenever a risk of pressure injury was identified for a study participant, wheelchair providers fabricated a pressure-relief cushion based on the WHO basic wheelchair service guidelines.

Data were collected between January and November 2019, by a group of eight data collectors from the University of El Salvador.

Study participants were interviewed during the wheelchair assessment (about 2 months before wheelchair delivery), at the wheelchair delivery visit, and at 3- and 6-month follow-up visits after wheelchair delivery. Participants who were not able to attend a follow-up visit were interviewed by phone. Data were collected using the following questionnaires and tools translated into Spanish which included demographic, clinical and wheelchair-related questions, wheelchair skills, maintenance patterns, poverty probability, quality of life, and all their health related questions. Data loggers (DLs) were also used to assess number of days of wheelchair use, daily distance traveled, and speed. Caregivers were interviewed to measure caregiver burden at baseline, at 3-month follow-up, and at 6-month follow-up. ;

Related Conditions & MeSH terms

• Wheelchair Users

• NCT number: NCT04936087
• Study type: Interventional
• Source: Momentum Wheels for Humanity
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Completion date: November 25, 2019